Parkinson's DiseasePhase 2/3NCT01968460

Safety, Tolerability and Efficacy of Two Doses of Once Daily P2B001 in Subjects With Early Parkinson's Disease

A Phase 2/3 study testing P2B001 once daily (pramipexole 0.6 mg / rasagiline 0.75 mg), and P2B001 once daily (pramipexole 0.3 mg / rasagiline 0.75 mg), in people with Parkinson's Disease, run by Pharma Two B Ltd. at 29 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will evaluate an oral fixed-dose, once daily product that combines pramipexole and rasagiline for the treatment of early Parkinson's disease. Animal studies support the therapeutic advantage of combining low doses of rasagiline and pramipexole and suggest further improvement when both are administered in a… Read more about this study

Who is it for?: Ages 35 to 75 years
Conditions the study is for: Parkinson's Disease
What is being tested?: P2B001 once daily (pramipexole 0.6 mg / rasagiline 0.75 mg), and P2B001 once daily (pramipexole 0.3 mg / rasagiline 0.75 mg),
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 149 participants
Where: 29 sitesin 2 countries
Study dates: Dec 2013to Jun 2015
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 35 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject is male or female ≥35 years of age to ≤75 years of age at the time of enrollment.
Subject has idiopathic Parkinson's disease consistent with the UK Brain Bank Criteria; must have bradykinesia with sequence effect and rest tremor or prominent motor asymmetry.
Subject with disease duration no longer than 3 years and 0 months.
Subject has a Hoehn \& Yahr (H\&Y) stage score of < 3.
Subject has a MMSE score ≥ 26

Who cannot join

Subject has an atypical parkinsonian syndrome or secondary parkinsonism (e.g., due to drugs, metabolic neurogenetic disorders, encephalitis, cerebrovascular disease or degenerative disease).
Subject has a history of psychosis or hallucinations within the previous 12 months.
Subject who is taking anticholinergic drugs.
Subject has previous exposure to levodopa or a dopamine agonist for longer than 4 weeks; if previous exposure was less than 4 weeks then it must not be within 2 months prior to the baseline visit.
Subject has previous exposure to a MAO-B inhibitor for longer than 4 weeks; if previous exposure was less than 4 weeks then it must not be within 3 months prior to the baseline visit.
Subject who is taking MAO inhibitors, potent CYP1A2 inhibitors, e,g, Ciprofloxacin, Dextromethorphan or antitussive agent, analgesic agents such as tramadol, meperidine, methadone and propoxyphene, strong 3A4 inducers, e.g., St. John's Wort or cyclobenzaprine (tricyclic muscle relaxant), dopamine antagonists, such as the neuroleptics (phenothiazines, butyrophenones, thioxanthenes) or metoclopramide. Probenecid, cimetidine, ranitidine, diltiazem, verapamil and quinidine.

Trial locations and contacts

29 sites in 2 countries.

Country

City, postcode or hospital

29 sites in 2 countries

United States24 sites

P2B001 Site Augusta
Augusta, Georgia
P2B001 Site Aurora
Aurora, Colorado
P2B001 Site Birmingham
Birmingham, Alabama
P2B001 Site Boca Raton
Boca Raton, Florida
P2B001 Site Boston
Boston, Massachusetts
P2B001 Site Camden
Camden, New Jersey
P2B001 site Chicago
Chicago, Illinois, 60612
P2B001 Site Cincinnati
Cincinnati, Ohio
P2B001 site Commack
Commack, New York
P2B001 Site Durham
Durham, North Carolina
P2B001 Site Golden Valley
Golden Valley, Minnesota
P2B001 Site Houston
Houston, Texas
P2B001 Site Kansas City
Kansas City, Kansas
P2B001 Site Los Angeles
Los Angeles, California
P2B001 Manchester
Manchester, Connecticut
P2B001 Site New Brunswick
New Brunswick, New Jersey
P2B001 Site New Haven
New Haven, Connecticut
P2B001 Site New York
New York, New York
P2B001 Site Port Charlotte
Port Charlotte, Florida
P2B001 Site Roanoke
Roanoke, Virginia
P2B001 Site Tampa
Tampa, Florida
P2B001 Site Toledo
Toledo, Ohio
P2B001 Site Tulsa
Tulsa, Oklahoma
P2B001 Site west Bloomfield
West Bloomfield, Michigan

Other trials in United States

Israel5 sites

P2B001 Site Rambam Israel
Haifa
P2B001 Site Belinson
Pethch Tikva
P2B001 Site Sheba Medical Center
Ramat Gan
P2B001 Site Asaf Harofe
Rishon LeZiyyon
P2B001 Site Sourasky Medical Center
Tel Aviv

Other trials in Israel

About this study

Official title: A Phase 2B, Twelve-week Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study, To Determine the Safety, Tolerability and Efficacy of Two Doses of Once Daily P2B001 in Subjects With Early Parkinson's Disease

This study will evaluate an oral fixed-dose, once daily product that combines pramipexole and rasagiline for the treatment of early Parkinson's disease.

Animal studies support the therapeutic advantage of combining low doses of rasagiline and pramipexole and suggest further improvement when both are administered in a sustained fashion. Both rasagiline and pramipexole are well known marketed drugs for Parkinson's disease with a good safety profile. combining the drugs in low doses and controlled release may provide better symptom management than the existing drugs alone or together.

Conditions: Parkinson's Disease
Being tested: P2B001 once daily (pramipexole 0.6 mg / rasagiline 0.75 mg),, Placebo, P2B001 once daily (pramipexole 0.3 mg / rasagiline 0.75 mg),
Keywords: Parkinson's Disease, Rasagiline, Pramipexole
Medical subject headings: Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

P2B001 once daily (pramipexole 0.6 mg / rasagiline 0.75 mg),Drug
Fixed Dose Combination of pramipexole 0.6 mg and rasagiline 0.75 mg once daily
PlaceboDrug
placebo
P2B001 once daily (pramipexole 0.3 mg / rasagiline 0.75 mg),Drug
Fixed Dose Combination of pramipexole 0.3 mg and rasagiline 0.75 mg once daily

Study groups in NCT01968460
Study group	Role	What they receive
P2B001 once daily (pramipexole 0.6 mg / rasagiline 0.75 mg),	Experimental	Fixed Dose Combination of pramipexole 0.6 mg and rasagiline 0.75 mg once daily. Receives: Drug: P2B001 once daily (pramipexole 0.6 mg / rasagiline 0.75 mg),
P2B001 once daily (pramipexole 0.3 mg / rasagiline 0.75 mg),	Experimental	Fixed Dose Combination of pramipexole 0.3 mg and rasagiline 0.75 mg once daily Receives: Drug: P2B001 once daily (pramipexole 0.3 mg / rasagiline 0.75 mg),
Placebo	Placebo comparator	Placebo once daily for 12 weeks. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Total UPDRS I, II, III Scores
Change from baseline to final visit (week 12) in total UPDRS score (defined as sum of parts I, II and III, scores (0-176). UPDRS- Unified Parkinson's Disease Rating Scale, minimum value is 0 points and maximum value is 176.
High score mean worse outcome.
Measured: Week 12

Secondary outcomes (4)

UPDRS ADL (Part II)
Change from baseline in individual UPDRS ADL (part II). Activity of daily Life UPDRS part II minimum is 0 point and max is 52 point (worse outcome)
Measured: Week 12
CGI-S
Change from baseline in individual Clinical Global Impression - Severity. Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness (Parkinson's Disease) at the time of assessment relative to the clinician's past experience with patients who have the same diagnosis as one of the following:. 1 is normal and 7 is the most extremely ill patients. A subject defined as a treatment responder when the improvement from baseline to the Week12 / Last Observed Value (LOV) was of at least 1 point or more.
Measured: 12 weeks
UPDRS Motor (Part III)
Change from baseline in individual UPDRS motor (part III). UPDRS- Unified Parkinson's Disease Rating Scale, part III motor . min is 0 and Max is 108 (Worse outcome)
Measured: 12 weeks
PDQ39
Change from baseline in individual Parkinson's Disease Questionnaire - 39. Score 0-100 where 0 is indicative of no problem at all and 100 is the maximum level of problem.
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2013Jun 2015

First posted24 Oct 2013 (estimated)
Study startDec 2013
Primary completionMay 2015
Study completionJun 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 149 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01968460
Sponsor's protocol ID: P2B001/001
Status last verified: Feb 2015
First submitted: 15 Oct 2013
Last updated: 7 Apr 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2B, Twelve-week Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study, To Determine the Safety, Tolerability and Efficacy of Two Doses of Once Daily P2B001 in Subjects With Early Parkinson's Disease
ClinicalTrials.gov ID: NCT01968460
Acronym / sponsor ID: P2B001/001
Conditions: Parkinson's Disease
Keywords: Parkinson's Disease, Rasagiline, Pramipexole
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 149 participants (actual)
Lead sponsor: Pharma Two B Ltd.Industry (pharma, biotech, devices)
Study start: Dec 2013
Primary completion: May 2015 (actual)
Study completion: Jun 2015 (actual)
First posted: 24 Oct 2013 (estimated)
Results: Posted 7 Apr 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study will evaluate an oral fixed-dose, once daily product that combines pramipexole and rasagiline for the treatment of early Parkinson's disease.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
P2B001 once daily (pramipexole 0.6 mg / rasagiline 0.75 mg),	Experimental	Drug: P2B001 once daily (pramipexole 0.6 mg / rasagiline 0.75 mg),Fixed Dose Combination of pramipexole 0.6 mg and rasagiline 0.75 mg once daily.
P2B001 once daily (pramipexole 0.3 mg / rasagiline 0.75 mg),	Experimental	Drug: P2B001 once daily (pramipexole 0.3 mg / rasagiline 0.75 mg),Fixed Dose Combination of pramipexole 0.3 mg and rasagiline 0.75 mg once daily
Placebo	Placebo comparator	Drug: PlaceboPlacebo once daily for 12 weeks.

Who may qualify

Ages: 35 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Subject is male or female ≥35 years of age to ≤75 years of age at the time of enrollment.
Subject has idiopathic Parkinson's disease consistent with the UK Brain Bank Criteria; must have bradykinesia with sequence effect and rest tremor or prominent motor asymmetry.
Subject with disease duration no longer than 3 years and 0 months.
Subject has a Hoehn \& Yahr (H\&Y) stage score of < 3.
Subject has a MMSE score ≥ 26

Key exclusion criteria (6 listed)

Subject has an atypical parkinsonian syndrome or secondary parkinsonism (e.g., due to drugs, metabolic neurogenetic disorders, encephalitis, cerebrovascular disease or degenerative disease).
Subject has a history of psychosis or hallucinations within the previous 12 months.
Subject who is taking anticholinergic drugs.
Subject has previous exposure to levodopa or a dopamine agonist for longer than 4 weeks; if previous exposure was less than 4 weeks then it must not be within 2 months prior to the baseline visit.
Subject has previous exposure to a MAO-B inhibitor for longer than 4 weeks; if previous exposure was less than 4 weeks then it must not be within 3 months prior to the baseline visit.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
P2B001 once daily (pramipexole 0.6 mg / rasagiline 0.75 mg),Fixed Dose Combination of pramipexole 0.6 mg and rasagiline 0.75 mg once daily	Drug	P2B001 once daily (pramipexole 0.6 mg / rasagiline 0.75 mg),
Placeboplacebo	Drug	Placebo
P2B001 once daily (pramipexole 0.3 mg / rasagiline 0.75 mg),Fixed Dose Combination of pramipexole 0.3 mg and rasagiline 0.75 mg once daily	Drug	P2B001 once daily (pramipexole 0.3 mg / rasagiline 0.75 mg),

Primary outcome

Total UPDRS I, II, III Scores
Time frame: Week 12
Change from baseline to final visit (week 12) in total UPDRS score (defined as sum of parts I, II and III, scores (0-176). UPDRS- Unified Parkinson's Disease Rating Scale, minimum value is 0 points and maximum value is 176. High score mean worse outcome.

4 secondary outcomes

UPDRS ADL (Part II)
Time frame: Week 12
CGI-S
Time frame: 12 weeks
UPDRS Motor (Part III)
Time frame: 12 weeks
PDQ39
Time frame: 12 weeks

Results and safety

Results posted to the registry on 7 Apr 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
P2B001 Treatment A	49	43
P2B001 Treatment B	50	45
Placebo	50	48

Primary outcome: Total UPDRS I, II, III Scores

Time frame: Week 12. Least squares mean (Standard Error). Unit: units on a scale

Measure	P2B001 Treatment A n = 49	P2B001 Treatment B n = 50	Placebo n = 50
Value	-5.97 (0.94)	-5.15 (0.9)	-1.31 (0.88)

P2B001 Treatment A vs Placebo: Mean Difference (Net): -4.67 (95% CI -7.20 to -2.13), p = 0.0004, MMRM
P2B001 Treatment B vs Placebo: Mean Difference (Net): -3.84 (95% CI -6.32 to -1.36), p = 0.0027, MMRM

Population analysed: ITT analyis

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 14 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
P2B001 Treatment A	1 of 49 (2%)	37 of 49 (75.5%)	0 of 49
P2B001 Treatment B	0 of 50 (0%)	20 of 50 (40%)	0 of 50
Placebo	0 of 50 (0%)	24 of 50 (48%)	0 of 50

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

pninit litman, Ph.D study director

Pharma Two B Ltd.

29 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in United States, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total UPDRS I, II, III Scores (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01968460.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2023.